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Investigating the Influence of Tablet Location Inside Dissolution Test Apparatus on Polymer Erosion and Drug Release of a Surface-Erodible Sustained-Release Tablet Using Computational Simulation Methods

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Abstract

The objective of this work was to investigate the influence of tablet location along the bottom of a USP apparatus II vessel on polymer erosion and drug release of surface-erodible sustained-release tablets using computational simulation methods. Computational fluid dynamics (CFD) methods were performed to simulate the velocity distribution. A mathematical model was developed to describe polymer erosion and tablet deformation according to the mass transfer coefficient. Numerical analysis was used to simulate drug release controlled by drug diffusion and polymer erosion. The results indicated that tablets located at the off-center position deformed faster than the tablets located at the center position. However, tablet location had no profound impact on drug release rate since all drug release profiles were “similar” according to the f2 similarity values which were above 50. Hence, our simulation supported that the USP apparatus II was a reliable and robust device for the dissolution testing of surface-erodible sustained-release tablets.

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References

  1. Qureshi SA, Shabnam J. Cause of high variability in drug dissolution testing and its impact on setting tolerances. Eur J Pharm Sci. 2001;12(3):271–6.

    Article  CAS  Google Scholar 

  2. Baxter JL, Kukura J, Muzzio FJ. Hydrodynamics-induced variability in the USP apparatus II dissolution test. Int J Pharm. 2005;292(1):17–28.

    Article  CAS  Google Scholar 

  3. Gao Z, Moore TW, Smith AP, Doub WH, Westenberger BJ. Studies of variability in dissolution testing with USP apparatus 2**Opinions expressed in this report are those of the authors and do not necessarily reflect the views or policies of the FDA. J Pharm Sci. 2007;96(7):1794–801.

    Article  CAS  Google Scholar 

  4. Feng X, Zidan A, Kamal NS, Xu X, Sun D, Walenga R, et al. Assessing drug release from manipulated abuse deterrentformulations. AAPS PharmSciTech. 2020;21(2):40.

    Article  CAS  Google Scholar 

  5. Meruva S, Rezaei L, Thool P, Donovan MD. Use of drug release testing to evaluate the retention of abuse-deterrent properties of polyethylene oxide matrix tablets. AAPS PharmSciTech. 2020;21(7):270.

    Article  CAS  Google Scholar 

  6. Bai G, Armenante PM. hydrodynamic, mass transfer, and dissolution effects induced by tablet location during dissolution testing. J Pharm Sci. 2009;98(4):1511–31.

    Article  CAS  Google Scholar 

  7. Zhang Y, Bredael G, Armenante PM. dissolution of prednisone tablets in the presence of an arch-shaped fiber optic probe in a USP dissolution testing apparatus 2. J Pharm Sci. 2013;102(8):2718–29.

    Article  CAS  Google Scholar 

  8. Ameur H, Bouzit M. 3D hydrodynamics and shear rates’ variability in the United States Pharmacopeia paddle dissolution apparatus. Int J Pharm. 2013;452(1):42–51.

    Article  CAS  Google Scholar 

  9. Cascone S. Modeling and comparison of release profiles: effect of the dissolution method. Eur J Pharm Sci. 2017;106:352–61.

    Article  CAS  Google Scholar 

  10. Pham AT, Lee PI. Probing the mechanisms of drug release from hydroxypropylmethyl cellulose matrices. Pharm Res. 1994;11(10):1379–84.

    Article  CAS  Google Scholar 

  11. Reynolds TD, Gehrke SH, Ajaz S. H, Shenouda LS. Polymer erosion and drug release characterization of hydroxypropyl methylcellulose matrices. J Pharm Sci. 1998;87(9):1115–23.

    Article  CAS  Google Scholar 

  12. Katzhendler I, Hoffman A, Goldberger A, Friedman M. Modeling of drug release from erodible tablets. J Pharm Sci. 1997;86(1):110–5.

    Article  CAS  Google Scholar 

  13. Zhou D, Law D, Reynolds J, Davis L, Smith C, Torres JL, et al. Understanding and managing the impact of HPMC variability on drug release from controlled release formulations. J Pharm Sci. 2014;103(6):1664–72.

    Article  CAS  Google Scholar 

  14. USP, USP General Chapter <711> Dissolution, second supplement of USP 35-NF30. 2012.

  15. Wang B, Bredael G, Armenante PM. Computational hydrodynamic comparison of a mini vessel and a USP 2 dissolution testing system to predict the dynamic operating conditions for similarity of dissolution performance. Int J Pharm. 2018;539(1):112–30.

    CAS  PubMed  Google Scholar 

  16. Wang B, Armenante PM. Experimental and computational determination of the hydrodynamics of mini vessel dissolution testing systems. Int J Pharm. 2016;510(1):336–49.

    Article  CAS  Google Scholar 

  17. Wilke CR, Chang P. Correlation of diffusion coefficients in dilute solutions. AICHE J. 1955;1(2):264–70.

    Article  CAS  Google Scholar 

  18. Gao P, Fagerness PE. Diffusion in HPMC Gels. I. Determination of drug and water diffusivity by pulsed-field-gradient spin-echo NMR. Pharm Res. 1995;12(7):955–64.

    Article  CAS  Google Scholar 

  19. Shah VP, Tsong Y, Sathe P, Liu JP. In vitro dissolution profile comparison—statistics and analysis of the similarity factor, f2. Pharm Res. 1998;15(6):889–96.

    Article  CAS  Google Scholar 

  20. FDA, Guidance for industry SUPAC-MR: modified release solid oral dosage forms. 1997.

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Correspondence to Hao Lou.

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Lou, H., Hageman, M.J. Investigating the Influence of Tablet Location Inside Dissolution Test Apparatus on Polymer Erosion and Drug Release of a Surface-Erodible Sustained-Release Tablet Using Computational Simulation Methods. AAPS PharmSciTech 22, 99 (2021). https://doi.org/10.1208/s12249-021-01979-y

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